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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, contact, polymethylmethacrylate, diagnostic
Product CodeHJK
Regulation Number 886.1385
Device Class 2


Premarket Reviews
ManufacturerDecision
RXSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 1 1
No Consequences Or Impact To Patient 1 1

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